MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2018-06-29 for BARD? CRITICORE? MONITOR 000002N manufactured by C.r. Bard, Inc. (covington) -1018233.
[112851925]
The reported issue of the monitor was confirmed. The root cause of the reported issue was isolated to a defective lcd. The criticore system identified in this record has been verified as model no. 000002n and contained obsolete parts. The model no. And obsolete parts were covered under? Notice of discontinuance and obsolescence? Letter. The system was not serviced, the repair order was cancelled and the monitor will be return to the facility. The device history record was reviewed and found nothing that could have caused or contributed to the reported event. The instructions for use state the following: "warning: the criticore monitor requires special precautions regarding emc and needs to be installed and put into service according to the emc information provided in the following tables. Portable and mobile rf communications equipment may affect the criticore monitor. Warning: the criticore monitor should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the criticore monitor should be observed to verify normal operation in the configuration in which it will be used. Warning: do not immerse or submerge the monitor or turn it upside down when cleaning. Caution: use only heavy-duty alkaline d cell batteries. Do not use rechargeable batteries. Do not incinerate batteries. Recycle or dispose of them properly. Contact bard for disposal information. Caution: improper orientation of the batteries within the battery pack can potentially damage the criticore monitor. Caution: state and federal regulations govern the packaging necessary for return of medical product which may have been contaminated. Refer to local, state and federal regulations when packaging the criticore monitor for return. Caution: there are no user serviceable components inside the criticore monitor. The user should not attempt to repair the criticore monitor. To do so may void the warranty and could result in erroneous monitor readings. Caution: use of cables or sensors other than those specified for use with the criticore monitor, except those sold by bard for use as replacement part or repair components, may result in increased emissions or decreased immunity of the criticore monitor. Caution: the criticore monitor should be recycled properly per european union directive 2002/96/ec on waste electronic and electrical equipment, january 27, 2003. Do not dispose with ordinary municipal waste. " the information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[112851926]
It was reported that during sample evaluation it was found that the the lcd was not displaying all segments in the container volume/flow rate quadrant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-02520 |
| MDR Report Key | 7652920 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2018-06-29 |
| Date of Report | 2018-06-29 |
| Date Mfgr Received | 2018-06-14 |
| Device Manufacturer Date | 2004-10-13 |
| Date Added to Maude | 2018-06-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AMY GRAVLEY |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD? CRITICORE? MONITOR |
| Generic Name | CRITICORE MONITOR |
| Product Code | EXS |
| Date Received | 2018-06-29 |
| Returned To Mfg | 2018-04-02 |
| Model Number | 000002N |
| Catalog Number | 000002N |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-29 |